BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 19008438 · Received March 29, 2024

    Report

    Report Number
    3006630150-2024-01934
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 20, 2024
    Report Date
    March 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7073269. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7073276.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED MODERATE DYSKINESIA. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE DEVICE WAS REPROGRAMMED, AND THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242287 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 744972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization